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RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 31 Mar 2026
Praxis Precision Medicines announces FDA acceptance and priority review of new drug application for relutrigine in patients with SCN2A and SCN8A DEEs
30 March 2026 - Praxis Precision Medicines today announced that the US FDA has accepted for priority review its new ...
Posted by Michael Wonder on 31 Mar 2026
Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab)
30 March 2026 - Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the ...
Posted by Michael Wonder on 31 Mar 2026
FDA approves new high dose regimen of Spinraza (nusinersen) for spinal muscular atrophy
30 March 2026 - The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety ...
Posted by Michael Wonder on 31 Mar 2026
Roche Korea to launch reimbursed Vabysmo pre-filled syringe in April, expanding retinal treatment options
30 March 2026 - Roche Korea said Monday that the Ministry of Health and Welfare has approved national health insurance ...
Posted by Michael Wonder on 31 Mar 2026
Zymeworks receives US FDA fast track designation for ZW191, a folate receptor alfa targeting antibody drug conjugate
30 March 2026 - Zymeworks today announced that the US FDA has granted fast track designation to ZW191, an antibody ...
Posted by Michael Wonder on 30 Mar 2026
Eli Lilly pushes for NHS drug price increases in return for its UK investment
30 March 2026 - US pharmaceutical group ‘optimistic’ about reaching deal with British Government. ...
Posted by Michael Wonder on 30 Mar 2026
Elevar Therapeutics announces FDA acceptance for review of new drug application for lirafugratinib as second-line cholangiocarcinoma treatment
30 March 2026 - Elevar Therapeutics today announced that the US FDA has completed its filing review of the new drug ...
Posted by Michael Wonder on 30 Mar 2026
ICER to assess treatments for hypertension
30 March 2026 - Report will be subject of Midwest CEPAC meeting in October 2026; draft scoping document open to ...
Posted by Michael Wonder on 30 Mar 2026
Leading cancer drug subsidised for thousands of patients
29 March 2026 - Health Minister Mark Butler has expanded the PBS listing of a leading cancer drug, giving more than ...
Posted by Michael Wonder on 29 Mar 2026
Enhertu followed by THP approved in China as the first and only HER2 directed ADC for the neo-adjuvant treatment of HER2 positive breast cancer
27 March 2026 - First approval of Daiichi Sankyo and AstraZeneca’s Enhertu globally in curative intent early breast cancer setting. ...
Posted by Michael Wonder on 29 Mar 2026
Expanded immunotherapy PBS listing to treat more cancers
29 March 2026 - The Albanese Government is continuing to deliver cheaper medicines with thousands more Australians living with advanced ...
Posted by Michael Wonder on 28 Mar 2026
Johnson & Johnson’s Darzalex (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers
27 March 2026 - Johnson & Johnson today announced that the CHMP of the EMA has granted approval for a Type ...
Posted by Michael Wonder on 28 Mar 2026
Sanofi’s Sarclisa subcutaneous formulation administered via on body injector recommended for EU approval by the CHMP to treat multiple myeloma
27 March 2026 - Recommendation based on positive results demonstrating comparable efficacy, pharmacokinetics, and safety of Sarclisa regimens administered subcutaneously compared ...
Posted by Michael Wonder on 28 Mar 2026
Richter receives European Commission approval for Fylrevy (estetrol tablet) as hormonal replacement therapy
27 March 2026 - Gedeon Richter announces today that the European Commission granted approval for the marketing authorisation of Fylrevy (estetrol; ...
Posted by Michael Wonder on 28 Mar 2026
Egetis announces FDA acceptance and priority review of NDA for Emcitate (tiratricol) for MCT8 feficiency
27 March 2026 - Egetis Therapeutics today announced that the US FDA has accepted the filing of its new drug application ...